FDA Issues Two Guidances on Voluntary Consensus Standards

The FDA issued two draft guidances on the use of voluntary consensus standards for medical devices.

The first guidance deals with the recognition and withdrawal of voluntary consensus standards. In developing the standards, the guidance states, recognized bodies must be open to all interested parties and must ensure that no single interest dominates the decision-making.

They must also ensure due process that includes documented and publicly-available policies and procedures and adequate notice of meetings, an impartial appeals process and consensus, the agency said.

The second draft guidance deals with the use of voluntary consensus standards in premarket submissions for devices and will replace guidance issued in 2007.